The eXciteOSA device delivers neuromuscular stimulation to the tongue to reduce snoring and mild sleep apnea
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Signifier Medical Technologies has secured approval from the US Food and Drug Administartion (FDA) for its new eXciteOSA device to reduce snoring and mild obstructive sleep apnea (OSA) in patients 18 years and older.
OSA is sleep-disordered breathing that takes place when the upper airway becomes blocked repeatedly during sleep, thereby reducing or completely stopping airflow.
It may cause serious complications such as heart attack, glaucoma, diabetes, cancer and cognitive and behavioral disorders.
The eXciteOSA is claimed to be the first device used while awake and intended to enhance tongue muscle function. It will help the tongue from collapsing backwards and obstructing the airway during sleep.
Signifier’s eXciteOSA is a removable tongue muscle stimulation device, which delivers neuromuscular stimulation to the tongue to reduce snoring and mild sleep apnea.
The device works by offering electrical muscle stimulation via a mouthpiece, which sits around the tongue. It features four electrodes, of which two are placed above the tongue and two are below the tongue.
The eXciteOSA offers electrical muscle stimulation action in sessions, which include a series of electrical pulses with rest periods in between.
It has to be used for 20 minutes once a day during a wakeful state for a period of six-weeks and once a week later.
The regulator evaluated the safety and efficacy of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild sleep apnea.
In the study, more than 20% reduction in time spent snoring at levels louder than 40dB was observed in 87 patients.
The FDA Centre for Devices and Radiological Health’s ophthalmic, anesthesia, respiratory, ENT and dental devices office director Dr Malvina Eydelman said: “Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated.
“Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea.”
In September 2020, Signifier secured $10m series C funding to invest further in its non-invasive solutions for patients with sleep disordered breathing conditions.